Translational Research and

Sample Handling

Linda Jones

Senior Research Sister

University of Cambridge and Cambridge ECMC

Introduction

• What is Translational

Research

• Why do we do it?

• Some basic terms

• Sample handling

• Bloods

• Tissue

• Other samples

• Nurses responsibilities

• Summary

What is Translational Research?

The Translational Research Working Group (NCI)

defines Translational Research in the following way:

"Translational research transforms scientific

discoveries arising from laboratory, clinical, or

population studies into clinical applications to

reduce cancer incidence, morbidity, and mortality."

Stand Up 2 Cancer (SU2C)

“Translational research can be pictured in the following way,” explains Nobel prizewinner Phillip Sharp, PhD, in an interview with Stand Up2Cancer. “I have a scientific insight. I develop a drug for that scientific insight, or a new therapeutic approach . . . You have to find the cancer patient who would respond to this drug, and you have to deliver it to that cancer patient in a compassionate and reasonable way to see if you can get maximal response.”

SU2C

Makes sense, right?

Then why is so much of the current research on

cancer restricted to the lab bench?

In order to get effective therapies to patients

quickly, there must be more support for the next

step of the process – the step wherein basic

science is translated into lifesaving treatment.

Translational Research

• Translational research involves moving knowledge and

discovery gained from the basic sciences to its

application in clinical settings.

• This concept is often summarised by the phrase "bench-

to-bedside" research.

• Brings the scientists ideas into reality (quickly).

• Often find translational research bolted on to studies

alongside the traditional PK and PD studies.

• Vital part of the Trial, not just an extra blood or tissue

sample.

• Often looking for biomarkers

Biomarkers

Biomarkers can be used to tell if:

– Treatment working

– Treatment stopped working

– Monitoring

May be from:

– Bloods

– Tissues

– Imaging

PK, PD

Recap from this morning:

Pharmacokinetics: PK is the study of what

the human body does to drugs to get the

drug out of the body

Pharmacodynamics: PD is the drugs effect

on the body and tumour

PG, BM

Pharmacogenetics: PG is the study of genetic differences in metabolic pathways which can affect individual responses to drugs

Biomarkers: BM is a measurable indicator of „biological state‟ and are often measured and evaluated to examine biological processes or pharmacologic responses to a drug or treatment.

Sample Handling

• Bloods

• Tissue

• Nurses responsibilities

– Training

– Recording

– Chain of custody / Material Transfer

Agreement

• Summary

Bloods –Top Tips

• If you use the laboratory or even handle samples - YOU MUST BE TRAINED!

• Ask at protocol development stage

• Understand the different tubes, especially if supplied by drug companies – Sarstedt and Monovettes use different systems and different colour tubes. Train on the correct system

• Understand what component of blood is required – it‟s vital to the research

• Centrifuges are individual and tricky and protocols need to be followed!

• Rubbish in = Rubbish out

Bloods stored in glass tubes

which were overfilled and

frozen

Blood Components

• Red Blood Cells

– used to carry Oxygen

• White Blood cells

– used to fight infection

• Plasma

• Serum

Blood components after

centrifugation

Plasma Serum

Difference between Plasma and

Serum

• Plasma contains fibrinogen and is the

liquid (cell free after centrifugation) part of

the blood

• Serum is the liquid part of blood after

coagulation, and therefore has no clotting

factors such as fibrinogen.

WARNING – both look identical after

centrifugation!

Tissue

• Formalin Fixed Paraffin

Embedded tissue

– FFPE

– Blocks

– Archived tissue

• Fresh tissue

– Liquid Nitrogen

– RNA-Later

• Many studies now ask for

one or both of these

Nursing Responsibilities

Training

• Everyone needs training

• Lab equipment is dangerous if used incorrectly

(and expensive when it breaks)

• Hazardous substances (LN2) – know your

COSHH (control of substances hazardous to

health)

• Correct use and handling of blood bottles,

tissue samples

Nursing Responsibilities

Recording and storage

• Accurate recording of samples is the most

important part of sample collection

• Document to the minute

• Don‟t „guestimate‟

• Document on the spot

• Rubbish in = Rubbish out

• Storage should be correct for the sample and

monitored

Nursing Responsibilities

Chain of Custody / Material transfer Agreements

• Check Consent

• Check everything is logged

• Ensure a MTA is in place

• If you can‟t find the correct agreements don‟t send it

• HTA will come calling

• Shipment must be correct for the sample (dry ice etc)

Summary

• Samples are an important part of early phase and translational research

• We can never go back to the same time point to get a missed/incorrect sample

• Know your responsibilities and get trained

• Document everything!

Remember – the patients want to take part in these studies and donate the samples to help this and future research. It is our responsibility to ensure we do the best we can with these precious samples